Mouth guard



34, 1967 P. 1.. JOHNSON ETAL 3,303,844

MOUTH GUARD Filed March 4. 1965 FIG] 1 N VENTORS PETER L. JOHNSON ROBERT P. EWING Mam ATTORNEY United States Patent 3,303,844 MGUTH GUARD Peter L. Johnson, Newark, and Robert P. Ewing, Morristown, N.J., assignors to Warner-Lambert Pharmaceutical Company, Morris Plains, N.J., a corporation of Delaware Filed Mar. 4, 1965. Ser. No. 437,086 Qlaims. (Cl. 128--136) This invention relates to mouth guards of the type generally used by athletes for protecting their teeth, lips and jaw from injury. More particularly, the present invention relates to new and novel mouth guards forming blanks for use in preparing custom-fitted mouth guards and to mouth guards prepared therefrom.

Mouth guards which protect teeth by serving as a cushion between the upper and lower teeth are well known. One such mouth guard commonly in use is a two-part structure comprising a U-shaped channel having a cushioned lining secured therein to receive and to closely fit about the teeth of a user. A typical example of such a guard is that disclosed by Chandler in US. Pat. No. 2,705,492. The basic difficulty, however, with this type guard is the uncomfortable fitting of the guard in the mouth which result-antly impairs normal breathing and speech. Since unimpaired breathing is a prime consideration for persons engaged in strenuous sporting activity as is clear speech in sports where instructions must be related to participants, it is desirable that the mouth guard be adapted to fit closely and comfortably about the users teeth. Because no two people have identical mouth configurations, it is generally considered to be impossible to mass produce mouth guards which properly fit and satisfy each users needs.

Various methods have been devised to provide mouth guards which are custom-fitted by competent individuals to the teeth of each user. These various attempts, however, have typically involved cumbersome procedures and materials which are ditficult to work with in properly forming and fitting a mouth guard for an individual. Resultantly, methods and materials for custom-fitting mouth guards as used heretofore have achieved little success and acceptance primarily because of the expense and diificulty of preparing such guards on a commercial basis.

It has now been found, however, that a new and novel mouth guard simply formed from mouth guard blanks composed of a multiple layered sheet of silicone materials in which the principal layers are characterized to serve and satisfy different requirements may now be prepared.

It is an object of this invention, therefore, to provide an improved mouth guard for protecting teeth and which may be commercially prepared in an economical and efiicient manner.

It is also an object of this invention to provide a new mouth guard having improved form-fitting, comfort and protection advantages.

It is a further object of this invention to commercially provide mouth guard blanks which are readily formed into custom-fitted mouth guards.

These and other objects and advantages of the present invention will become more apparent from the following detailed description taken in combination with the accompanying drawing in which:

FIG. 1 illustrates a top elevational view of a mouth guard blank;

FIG. 2 is a right side elevational view thereof illustrating the mouth guard blank as it may appear composed of two layers;

FIG. 3 is a perspective view showing a mouth guard formed from a cast impression mold;

FIG. 4 is a top elevational view of the prepared mouth guard;

FIG. 5 is a cross-section elevational view illustrating the method by which the mouth guard blank of FIG. 1 is fitted about an impression mold; and

FIG. 6 illustrates in general cross-section the manner the prepared mouth guard of the present invention fits in place about the upper posterior teeth.

Referring to FIGS. 1 and 2 of the drawing, blank mouth piece 10 composed of first layer 12 and second layer 14 are formed from a continuous sheet of silicone rubber material by efiicient manufacturing methods so as to provide a guard having greatly increased utility in protecting a users teeth.

Initially, first layer 12 which may also be designated the inner layer coming into contact with the upper teeth is formed as a sheet having a thickness of about 0.8 mm. to about 1.5 mm. and preferably about 1 mm. thick. The physical characteristics of first layer 12 appears in the cured state as follows:

Hardness, Shore A 44 Tensile strength, p.s.i 775 Elongation, percent 320 Tear strength, lbs/in. 28

An example of suitable material having the desirable properties indicated above is that commercially available from the General Electric Silicon Products Department as CE-4201. This material is known as a single component cure material; that is, a separate catalyst is not required to initiate the polymerization action in order to cure the material from the soft, putty state to the tough elastic state. Triggering of the cure to the tough elastic state is accomplished simply by dry heating of the putty material at a temperature in the neighborhood of about 300 F. to about 400 F. and usually about 350 F. over about a 10- to 15-minute heating interval. In the cured state, the material of inner layer 12 may be characterized as being strong and yieldable while creating the sensation of softness when in place in the mouth about the teeth and gum tissue.

Simultaneously, with the formation of a sheet of material from which first layer 12 is formed, there is formed a continuous sheet of material for second layer 14. The second layer material is rolled as a continuous sheet having a uniform thickness slightly greater than that of first layer 12 and typically within a range of about 1 to about 3.5 mm. The material of second layer 14 is also a single component cure composition similar to that forming first layer 12 although more resistant to bitethrough by teeth while having a general sensation of being firm and smooth when in place in the mouth of the user. The physical characteristics of the material forming second layer 14 appear in the cured state as follows:

Hardness, Shore A 66 Tensile strength, p.s.i 1480 Elongation, percent 480 Tear strength, lbs./ in.

An example of suitable material having the desirable properties indicated for second layer 14 is that commercially available from the General Electric Silicone Products Department as CE-4808.

First layer 12 and second layer 14 are formed of compositions rgenerally composed of ingredients such as dimethylpolysiloxane, silica, titanium dioxide and iron oxide. The mate-rials employed to form first layer 12 and second layer 14 of blank mouth guard 10 illustrated in FIGS. 1 and 2 are laminated together while in the putty or uncured state such that the finally prepared mouth guard which results is characterized as a comfortable and good fitting guard affording adequate protection when in use.

Prior to laminating the uncured materials forming first layer 12 and second layer 14, it is apparent that suitable reinforcing materials may be interposed as an intermediate layer. Materials found useful as an intermediate layer are generally meshed or knitted nylon, dacron, Tefion, orlon, or cotton canvas. When employed as an intermediate layer, these materials serve to strengthen the mouth guard in both the cured and uncured states. In addition, when an intermediate layer is employed, first layer 12 and second layer 14 may be constructed of reduced thickness without adversely affecting the necessary protection required of the guard during use.

Referring to FIG. 3 of the drawing, protective mouth guard 16 is illustrated in the cured state after being removed from mold 18 formed from a dental impression taken of the users teeth. Although mouth guard 16 is illustrated formed about mold 18 of the upper teeth to form a perfect fit of the upper teeth of the individual from whom the original dental impression is taken, it may also be conveniently formed about the lower teeth of an individual. Mold 18 may be marked by identification plate 20 in accordance with customary dental practice to provide a permanent record of an individuals teeth in case duplicate or additional mouth guards become necessary or are desired.

FIG. 3 also illustrates first layer 12 and second layer 14 as they appear in finally prepared mouth guard 16 while FIG. 4 further illustrates the prepared mouth guard as it appears from the top elevational view.

FIG. illustrates the anterior teeth of impression mold 22 over which the second or outer layer 14 of mouth guard 16 appears encasing inner or first layer 12.

FIG. 6 shows mouth guard 16 as it appears in place protecting the upper posterior teeth 24, generally illustrated.

With regard to the procedure for forming the protective mouth guard of the present invention from blank 10, initially a quick setting alginate impression material is used to take a full impression of the upper dental arch. Thereafter, stone material is carefully poured into the full impression while employing a vibrator to assure complete molding of the stone. The poured stone is then allowed to harden and the mold so formed is removed from the impression and allowed to completely dry. An indelible pencil is employed, if desired, to outline the proposed borders of the mouth guard on the dry stone surface. Thereafter, the formed blank mouth guard illustrated in FIGS. 1 and 2 is placed over the surfaces of the molded stone with the palatal area about As-inch short of the penciled outline and with first layer 12 being in position over the tooth or cast side. With finger pressure, the blank mouth guard is pushed and pressed into position over the teeth. Any excess material which may appear is then removed by trimming the mouth guard material at the penciled outline on the palatal portion of the cast. By following the procedure of pressing the blank mouth guard into place as indicated above, greater amounts of soft inner material appear in sensitive areas about the gum tissue and teeth While the second or outer layer essentially comprises a smooth uniformly formed surface about the inner layer as illustrated in FIG. 5.

After the blank mouth guard is in place on the molded stone, the stone is heated to about 350 F. in an oven for about 10 minutes or such comparable temperature and time period to effect curing of the mouth guard material. Upon curing, the stone cast is removed from the oven and allowed to cool after which the mouth guard may be removed from the cast and trimmed of any rough edges which may appear along the border area. After washing and sterilization in boiling water the mouth guard is ready for use.

A particular advantage which results by employing the present materials in forming mouth guards is that the guards may be sterilized by heating in boiling water any time after curing. In addition, the present mouth guards are found to have an indefinite life in that they do not become brittle and hard with age nor are they subject to excessive wear when in use.

It is understood that the foregoing detailed description is given merely by Way of illustration and that many variations may be made therein without departing from the spirit of this invention.

What is claimed is:

1. A mouth guard blank for use in preparing a protective mouthpiece of the type which is individually fitted to engage over and about the teeth of the upper jaw which comprises, a first layer of polysiloxane material having a thickness of about 0.8 mm. to about 1.5 mm., and a second layer of polysiloxane material having an original thickness of about 1 mm. to about 3.5 mm., said first and second layer materials being curable from a soft putty state to a tough elastic state by dry heating to a temperature of about 300 F. to about 400 F.

2. A mouth guard blank for use in preparing a protective mouthpiece of the type which is individually fitted to engage over and about the teeth of the upper jaw which comprises:

(A) A first layer of polysiloxane material having a thickness of about 0.8 mm. to about 1.5 mm. and characterized in the cured state by a tensile strength of about 775 p.s.i. and a tear strength of about 28 lbs./in.;

(B) A second layer of polysiloxane material having a thickness of about 1 mm. to about 3.5 mm. and characterized in the cured state by a tensile strength of about 1480 p.s.i. and a tear strength of about lbs./in.;

(C) Said first and second layer materials being curable from a soft putty state to a tough elastic state by dry heating to a temperature of about 300 F. to about 400 F.

3. A protective mouthpiece of the type which is individually fitted to engage over and about the teeth of the upper jaw which comprises a first layer of polysiloxane material having an original thickness of about 0.8 mm. to about 1.5 mm., and a second layer of polysiloxane material having an original thickness of about 1 mm. to about 3.5 mm., said first and second layer materials being curable from a soft putty state to a tough elastic state by dry heating to a temperature of about 300 F. to about 400 F.

4. A protective mouthpiece of the type which is individually fitted to engage over and about the teeth of the upper jaw which comprises:

(A) A first layer of polysiloxane material having a thickness of about 0.8 mm. to about 1.5 mm. and characterized in the cured state by a tensile strength of about 775 p.s.i. and a tear strength of about 28 lbs./in.;

(B) A second layer of polysiloxane material having a thickness of about 1 mm. to about 3.5 mm. and characterized in the cured state by a tensile strength of about 1480 p.s.i. and a tear strength of about 150 lbs./in.;

(C) Said first and second layer material being curable from a soft putty state to a tough elastic state by dry heating to a temperature of about 300 F. to about 400 F.

5. A mouth guard blank for use in preparing a protective mouthpiece of the type which is individually fitted to engage over and about the teeth of the upper jaw which comprises, a first layer of polysiloxane material having a thickness of about 0.8 mm. to about 1.5 mm.; an intermediate layer of mesh fabric selected from the 7 group consisting of nylon, dacron, Teflon, orlon and coti0 canvas; and a second layer of polysiloxane material having an original thickness of about 1 mm. to about 3.5 mm., said first and second layer materials being curable from a soft putty state to a tough elastic state by dry heating to a temperature of about 300 F. to about 400 F.

6. A mouth guard formed from the mouth guard blank of claim 5.

7. A mouth guard blank for use in preparing a protective mouthpiece of the type which is individually fitted to engage over and about the teeth of an individual which comprises, a first layer of polysiloxane material having a thickness of about 0.8 mm. to about 1.5 mm., and a second layer of polysiloxane material having an original thickness of about 1 mm. to about 3.5 mm., said first and second layer materials being curable from a soft putty state to a tough elastic state by dry heating to a temperature of about 300 F. to about 400 F.

8. A protective mouthpiece of the type which is individually fitted to engage over and about the teeth of an individual which comprises a first layer of polysiloxane material having an original thickness of about 0.8 mm. to about 1.5 mm., and a second layer of polysilox ane material having an original thickness of about 1 mm. to about 3.5 mm., said first and second layer materials being curable from a soft putty state to a tough elastic 5 state by dry heating to a temperature of about 300 F. to about 400 F.

9. A mouth guard blank for use in preparing a protective mouthpiece of the type which is individually fitted to engage over and about the teeth of an individual which comprises, a first layer of polysiloxane material having a thickness of about 0.8 mm. to about 1.5 mm.; an intermediate layer of mesh fabric selected from the group consisting of nylon, dacron Tefion, orlon and cotton canvas; and a second layer of polysiloxane material having an original thickness of about 1 mm. to about 3.5 mm., said first and second layer materials being curable from a soft putty state to a tough elastic state by dry heating to a temperature of about 300 F. to about 400 F.

10. A mouth guard formed from the mouth guard blank of claim 9.

References Cited by the Examiner UNITED STATES PATENTS ADELE M. EAGER, Primary Examiner. 

2. A MOUTH GUARD BLANK FOR USE IN PREPARING A PROTECTIVE MOUTHPIECE OF THE TYPE WHICH IS INDIVIDUALLY FITTED TO ENGAGE OVER AND ABOUT THE TEETH OF THE UPPER JAW WHICH COMPRISES: (A) A FIRST LAYER OF POLYSILOXANE MATERIAL HAVING A THICKNESS OF ABOUT 0.8 MM. TO ABOUT 1.5 MM. AND CHARACTERIZED IN THE CURED STATE BY TENSILE STRENGTH OF ABOUT 775 P.S.I. AND A TEAR STRENGTH OF ABOUT 28 LBS./IN.; (B) A SECOND LAYER OF POLYSILOXANE MATERIAL HAVING A THICKNESS OF ABOUT 1 MM. TO ABOUT 3.5 MM. AND CHARACTERIZED IN THE CURED STATE BY A TENSILE STRENGTH OF ABOUT 1480 P.S.I. AND A TEAR STRENGTH OF ABOUT 150 LBS./IN.; (C) SAID FIRST AND SECOND LAYER MATERIALS BEING CURABLE FROM A SOFT PUTTY STATE TO A TOUGH ELASTIC STATE BY DRY HEATING TO A TEMPERATURE OF ABOUT 300*F. TO ABOUT 400*F. 